MAUDE Adverse Event Report: ZIMVIE US CORP LLC IMP,TSV,4.1MM,SBM,11.5; DENTAL IMPLANT

Catalog Number	TSV4B11
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A1: patient identifier: unknown / not provided.A4: patient weight: unknown / not provided.E1: reporter name: unknown / not provided.
Event or Problem Description
The doctor reports that the dental implant located in position number 15 failed because it fractured at the head and was removed.The doctor reports that the procedure was not concluded by placing another implant.Pain was reported as a result of the event.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).The following fields have been updated: b4: date of this report.B5: describe event or problem.G3: date received by manufacturer.G6: type of report.H1: type of reportable event.H2: follow up type.H6: adverse event problem: corrected.H11: additional narrative.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).Zimvie received one (1) tsv4b11, (imp,tsv,4.1mm,sbm,11.5) for evaluation.Visual evaluation of the as returned device identified the implant with signs of use, apparent bone/tissue attached to external threads.The implant has evidence of being trephined and a fractured removal tool fragment was identified stuck inside the implant.However, during a follow up the customer indicated the removal tool fractured during the implant removal process.The implant itself was not identified fractured.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.This complaint refers to the specific device being investigated for this complaint record.Dhr review was completed for the subject lot number 1244532.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Complaint history review was performed for the reported lot number 1244532 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿fracture implant¿ a definitive root cause could not be determined since the device malfunction did not occur, and the reported event has been unconfirmed following visual testing and physical evaluation.Therefore, based on the available information, the implant malfunction did not occur.The reported event was unconfirmed with all the available information.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the product was nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.At this time, the complaint investigation has been completed and the record will be closed.If additional information is received, the record will be re-opened for further evaluation.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: IMP,TSV,4.1MM,SBM,11.5
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ZIMVIE US CORP LLC; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): ZIMVIE US CORP LLC; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: mark mashburn ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 24568606
• Report Number: 0001038806-2026-01296
• Device Sequence Number: 9500141
• Product Code: DZE
• UDI-Device Identifier: 00889024019232
• UDI-Public: (01)00889024019232(17)260520(10)1244532
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K072589
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 05/20/2026
• Device Catalogue Number: TSV4B11
• Device Lot Number: 1244532
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/19/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 03/11/2026; 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic